| CTRI Number |
CTRI/2016/07/007096 [Registered on: 15/07/2016] Trial Registered Prospectively |
| Last Modified On: |
27/07/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Biological |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A pharmacokinetic and pharmacodynamic study of pegfilgrastim (test drug) with Neulasta of Amgen (reference drug, EU Licensed Product) in normal adult human subjects under fasting conditions. |
|
Scientific Title of Study
|
An assesor blind, balanced, randomized, two-treatment, two period, single-dose, two way crossover, comparative subcutaneous pharmacokinetic and pharmacodynamic study of two dose levels of INTP5 of Intas pharmaceuticals ltd., India Ahmedabad, India with two dose levels of Neulasta of Amgen (EU licensed product) in healthy, normal adult human subjects under fasting condition. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 154-14, Version: 02, Date: 09/02/2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akash Patel |
| Designation |
Principal Investigator |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202488 |
| Fax |
07940202021 |
| Email |
akashpatel@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akash Patel |
| Designation |
Principal Investigator |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202488 |
| Fax |
07940202021 |
| Email |
akashpatel@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tarak Parikh |
| Designation |
Co-Investigator |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202286 |
| Fax |
07940202021 |
| Email |
tarakparikh@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
| Intas Pharmaceuticals Ltd. Plot no 423/P/A, Sarkhej-Bavla highway Village: Moraiya, Taluka: Sanand Ahmedabad 382213 Gujarat, India, Tel. No: 02717660100 Fax: 02717660105 |
|
|
Primary Sponsor
|
| Name |
Intas Pharmaceuticals Ltd |
| Address |
Plot no 423/P/A, Sarkhej-Bavla highway Village: Moraiya, Taluka: Sanand Ahmedabad 382213 Gujarat, India, Tel. No: 02717660100 Fax: 02717660105 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akash Patel |
Lambda Therapeutic Research Ltd |
Plot No. 38, Near Silver Oak Club, S. G. Highway, Gota, Ahmedabad
Ahmadabad
GUJARAT |
07940202488
07940202021
akashpatel@lambda-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee-Aditya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neulasta® of AMGEN® |
Dose:3 mg; Frequency: Single dose; Mode of Administration: Subcutaneous Injection; Duration of treatment: One day |
| Comparator Agent |
Neulasta® of AMGEN® |
Dose:6 mg; Frequency: Single dose; Mode of Administration: Subcutaneous Injection; Duration of treatment: One day |
| Intervention |
Pegfilgrastim manufactured by Intas Pharmaceuticals Ltd |
Dose:3 mg; Frequency: Single dose; Mode of Administration: Subcutaneous Injection; Duration of treatment: One day
|
| Intervention |
Pegfilgrastim manufactured by Intas Pharmaceuticals Ltd |
Dose:6 mg; Frequency: Single dose; Mode of Administration: Subcutaneous Injection; Duration of treatment: One day
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Non-smoking, healthy, normal, adult human volunteers between 18 to 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
2. Having a Body Mass Index (BMI) between 18.5 – 24.9 kg/m2 (both inclusive), and weight not <50 kg or > 100 kg.
3. Not having any significant disease in medical history or clinically significant abnormal findings during screening, abdominal ultrasonography, medical history, physical examination, laboratory evaluations, 12-lead ECG and X-ray chest (P/A view) recordings.
4. Ability to communicate effectively with study personnel.
5.Willingness to adhere to the protocol requirements.
6. Able to understand and give written informed consent for participation in the trial.
7. Both male and female patients of child bearing potential must be practicing adequate contraception.Female patients of child-bearing potential must not be orlikely to be pregnant or lactating and must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization.
|
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity to the study drug or its constituents
2. Known case of hereditary fructose intolerance
3. Any clinically significant laboratory finding including ANC (Absolute Neutrophil Count), CD 34+, platelet or hemoglobin at the time of screening.
4. History or presence of other systemic disorders or diseases (e.g., haemopoietic, renal, hepatic, cardiovascular, respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement).
5. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
6. Subjects with a history of pulmonary infiltrate or pneumonia in the previous 6 months from the date of the screening visit.
7. History of any hematologic disease including sickle cell disorders
8. Receipt of over-the-counter medicines which have not yet cleared from the body (five half-lives must have passed for the medicine to be considered to have cleared from the body).
9. Smokers, or who have smoked within last six months prior to start of the study.
10. Consumption of tobacco or tobacco containing products within last six months prior to start of the study.
11. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
12. The presence of clinically significant abnormal laboratory values during screening.
13. Positive result for human immunodeficiency virus (HIV I &/or II) and/or hepatitis B and C tests.
14. History or presence of psychiatric disorders.
15. Consumption of grape fruit or grape fruit products within 72 hours prior to receiving study drug.
16. A history of difficulty in donating blood.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cmax, AUC0-t |
Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of drug related Adverse Events as assessed by clinical examination, vitals and/or laboratory parameters for both the treatments |
Day 28 |
|
|
Target Sample Size
|
Total Sample Size="344"
Sample Size from India="344"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
Modification(s)
|
Phase 1 |
|
Date of First Enrollment (India)
|
16/07/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The objective of this study is to compare
the pharmacokinetic and pharmacodynamic effects and to assess bioequivalence of
two dose levels of INTP5 of Intas Pharmaceuticals Ltd., India against two dose
levels of Neulasta® of AMGEN (EU licensed Products) after single
subcutaneous dose administration in adult, normal healthy subjects.
Through this study, we will prospectively
collect the data on healthy subjects that are randomly assigned to receive
either INTP5 of Intas Pharmaceuticals Ltd., India or Neulasta of AMGEN (EU
licensed Product-marketed by AMGEN Europe, BV) for the pharmacokinetic and
pharmacodynamic profiling. No additional tests apart from already specified,
will be performed. The study will therefore not put any additional risk/burden
to the subjects. |